Eligibility of patients with type 2 diabetes for sodium‐glucose co‐transporter‐2 inhibitor cardiovascular outcomes trials: An assessment using the Diabetes Collaborative Registry

Wittbrodt, Eric; Chamberlain, David G.; Arnold, Suzanne V.; Tang, Fengming; Kosiborod, Mikhail

doi:10.1111/dom.13738

Cited by 18 publications

(24 citation statements)

References 19 publications

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“…Similar analyses have been performed on CVOTs for SGLT‐2is . Nicolucci et al 11 showed that real‐world T2D patients eligible for CVOTs on SGLT‐2is were different to trial populations in many instances .…”

Section: Discussionmentioning

confidence: 87%

“…A few studies have examined what proportion of T2D patients from various clinical care settings would satisfy I/E criteria to be enrolled in specific CVOTs, but no study to date has examined what the proportion is of real‐world patients that corresponds to CVOT populations. Indeed, applying CVOT enrolment criteria to real‐world T2D patients yields subgroups that are substantially different from the actual CVOT populations, thereby leaving the question of generalizability unanswered.…”

Section: Introductionmentioning

confidence: 99%

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Enrolment criteria for diabetes cardiovascular outcome trials do not inform on generalizability to clinical practice: The case of glucagon‐like peptide‐1 receptor agonists

Sciannameo

Berchialla

Orsi

et al. 2020

Diabetes Obesity Metabolism

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Aim: To evaluate the generalizability of cardiovascular outcome trials (CVOTs) on glucagon-like peptide-1 receptor agonists (GLP-1RAs), we assessed what proportion of real-world patients with type 2 diabetes (T2D) constitute true CVOT-like populations. Materials and Methods: We applied inclusion/exclusion (I/E) criteria of each GLP-1RA CVOT to a cross-sectional database of 281 380 T2D patients from Italian diabetes outpatient clinics. We calculated the proportion of patients eligible for each CVOT and compared their clinical characteristics with those of trial patients. In addition, we used a Bayesian network-based method to sample the greatest subsets of real-world patients yielding true CVOT-like populations.Results: Between 98 725 and 124 164 T2D patients could be evaluated for CVOT eligibility. After excluding patients who were already on GLP-1RAs and applying I/E criteria, 35.8% of patients would be eligible for REWIND, 34.1% for PIONEER-6, 13.4% for EXSCEL, 10.1% for SUSTAIN-6, 9.5% for HARMONY and 9.4% for LEADER. Overall, 45.4% of patients could be eligible for at least one of the CVOTs.These patients, however, were extremely different to trial patients in most of the clinical characteristics, including demographics, concomitant medications and complications. The greatest CVOT-like subsets of real-world patients were 0.5% for SUSTAIN-6, 1.0% for EXSCEL, 1.2% for LEADER, 1.8% for PIONEER-6 and 7.9% for REWIND. Conclusions:A very small proportion of real-world patients constitute true CVOTlike populations. These findings question whether any meaningful information can be drawn from applying trial enrolment criteria to real-world T2D patients. K E Y W O R D S cardiovascular disease, glucagon-like peptide-1 analogue, pharmaco-epidemiology, population study, type 2 diabetes

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Section: Discussionmentioning

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Enrolment criteria for diabetes cardiovascular outcome trials do not inform on generalizability to clinical practice: The case of glucagon‐like peptide‐1 receptor agonists

Sciannameo

Berchialla

Orsi

et al. 2020

Diabetes Obesity Metabolism

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“…It is important to recognize the differences in eligibility criteria when considering the applicability of these results to the usual care of T2D patients. In 172 643 patients from the Diabetes Collaborative Registry, for example, the proportion of patients eligible for CVOTs ranged from 26% (EMPA‐REG OUTCOME) to 44% (DECLARE) and 48% of patients were ineligible for all CVOTs …”

Section: Cardiorenal Outcomes From Cardiovascular Outcome Trialsmentioning

confidence: 99%

“…The arrow indicates reduced risk; the symbol "=" indicates neutrality the usual care of T2D patients. In 172 643 patients from the Diabetes Collaborative Registry, for example, the proportion of patients eligiblefor CVOTs ranged from 26% (EMPA-REG OUTCOME) to 44% (DECLARE) and 48% of patients were ineligible for all CVOTs 35. THE NEAR FUTUREThe near future is likely to bring new insights to the therapeutic strategy for T2D.…”

mentioning

confidence: 99%

Primary versus secondary cardiorenal prevention in type 2 diabetes: Which newer anti‐hyperglycaemic drug matters?

Giugliano

Ceriello

Nicola

et al. 2019

Diabetes Obesity Metabolism

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We are observing a resurgence of major diabetic vascular complications after a period of dramatic decrease during the period 1990 to 2010. The classical division of cardiovascular prevention into primary (with an event) and secondary (without an event) is largely used to describe cardiovascular risk in type 2 diabetes (T2D); however, there is evidence that the cardiovascular risk in diabetes may range from highest in patients who experienced a previous cardiovascular event to mild in patients with the main risk factors at target. Herein, we present details of the 14 cardiovascular outcome trials (CVOTs) published to date, including the total population investigated, and their separation into primary (T2D + multiple risk factors) and secondary prevention (T2D + established cardiovascular disease [CVD]) populations as detailed within the trials. We also summarize evidence for the effects of dipeptidyl peptidase‐4 inhibitors (DPP‐4i), glucagon‐like peptide‐1 receptor agonists (GLP1‐RA) and sodium glucose co‐transporter‐2 inhibitors (SGLT‐2i) versus placebo on the risk of major cardiovascular events (MACE), heart failure (HF) and diabetic kidney disease (DKD). In primary prevention, SGLT‐2i reduce both the risk of hospitalization for HF and progression of DKD; in secondary prevention, SGLT‐2i are effective on the three endpoints, DPP‐4i are neutral, while GLP1‐RA show mixed results.

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“…Interestingly, a high proportion of patients initiating dapagliflozin in routine clinical practice satisfied DECLARE-TIMI 58 enrolment criteria. For comparison, Wittbrodt et al reported that the eligibility of patients in the Diabetes Collaborative Registry was much lower for other CVOTs with SGLT2i, thereby suggesting a higher generalizability of the DECLARE-TIMI 58 population in the southern European population [25]. However, it should be noted that, even among patients who satisfied DECLARE-TIMI 58 eligibility criteria and received dapagliflozin, significant differences were found compared to the actual DECLARE-TIMI 58 population.…”

Section: Discussionmentioning

confidence: 99%

A Multinational Real-World Study on the Clinical Characteristics of Patients with Type 2 Diabetes Initiating Dapagliflozin in Southern Europe

Fadini¹,

Tentolouris

Bellido

et al. 2019

Diabetes Ther

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Introduction: A real-world study was performed to describe the clinical characteristics of patients who received dapagliflozin to better understand differences when initiating dapagliflozin in various countries and different prescribing settings. Methods: We assessed pooled data from observational studies carried out in Italy (n = 2484), Spain (n = 564) and Greece (n = 87). The primary objective was to compare the clinical profile of patients initiating dapagliflozin in the three countries. We also evaluated the percentage of patients who received dapagliflozin in clinical practice who satisfied DECLARE-TIMI 58 enrolment criteria. Results: In Italy and Spain, around 90% of patients were receiving metformin vs. 66% in Greece (p \ 0.0001). Patients in Greece had lower levels of estimated glomerular filtration rate and lower prevalence rates of retinopathy, prior stroke, acute myocardial infarction, peripheral arterial disease and atherosclerotic cardiovascular disease. Grouping the cohorts by prescribing setting (primary vs. specialist care), baseline HbA 1c was lower in primary care (8.4 ± 1.7 vs. 8.7 ± 1.5, respectively; p \ 0.0001). Significantly more patients were receiving other medications for concomitant conditions in specialist care. A total of 1416 patients (48%) did not meet DECLARE inclusion criteria, while 1561 (52%) patients met the criteria (Greece 41.05%, Italy 53.19%, Spain 51.35%). Conclusions: Significant differences were seen among patients initiating dapagliflozin in southern Europe. Our results suggest that dapagliflozin was being initiated at different Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11316458.

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Eligibility of patients with type 2 diabetes for sodium‐glucose co‐transporter‐2 inhibitor cardiovascular outcomes trials: An assessment using the Diabetes Collaborative Registry

Cited by 18 publications

References 19 publications

Enrolment criteria for diabetes cardiovascular outcome trials do not inform on generalizability to clinical practice: The case of glucagon‐like peptide‐1 receptor agonists

Enrolment criteria for diabetes cardiovascular outcome trials do not inform on generalizability to clinical practice: The case of glucagon‐like peptide‐1 receptor agonists

Primary versus secondary cardiorenal prevention in type 2 diabetes: Which newer anti‐hyperglycaemic drug matters?

A Multinational Real-World Study on the Clinical Characteristics of Patients with Type 2 Diabetes Initiating Dapagliflozin in Southern Europe

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